Table 3. Ongoing trials studying the anticoagulation treatment in patients with AF and HF, who underwent TAVI.
Study Name | Duration | Type | Expected population (participants) | AF patients | Comparators | Primary endpoint |
1Described adverse event composite includes all-cause death, MI, ischemic stroke, systemic embolic events (SEE), valve thrombosis, and major bleeding per definition of the International Society on Thrombosis and Hemostasis.
2The composite of all-cause death, TIA/stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep venous thrombosis, systemic embolism, life-threatening, disabling or major bleeding, according to the Valve Academic Research Consortium definitions. 3Death from any cause, myocardial infarction, stroke all causes, valve thrombosis and hemorrhage ≥ 2 as defined by the VARC 2 (Valve Academic Research Consortium scale). AF: atrial fibrillation; MI: myocardial infarction; NA: not available; NOAC: non-vitamin K oral anticoagulants; RCT: randomized-control trial; SEE: systemic embolic events; TAVI: transcatheter aortic valve implantation. | ||||||
ENVISAGE-TAVI AF[76] | 2017−2021 | RCT | 1,400 | All | Edoxaban vs. Warfarin | Number of participants experiencing the described adverse event composite within 36 months.1 |
ATLANTIS[77] | 2016−2020 | RCT | 1509 | Stratum 1 (patients requiring lifetime OAC) | Apixaban vs. Warfarin | Composite Primary Endpoint in 12 months.2 |
AVATAR | 2017−2020 | RCT | 170 | NA | NOAC vs. NOAC + aspirin | Composite Primary Endpoint in 12 months.3 |